Mucosal Immunotherapy for Peanut Allergy
The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
Description
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (MIT). We are also studying the effect of peanut MIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six with peanut allergy will be randomized to peanut MIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the DCRU. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut MIT using appropriate statistical analysis.
Status: Active, not recruiting (N/A). Started on March 1st, 2007.
Enrollment: 45 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Crossover Assignment
- Masking: Double Blind (Subject
- Caregiver
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Other: Peanut flour
- Dietary Supplement: Oat
- Other: Peanut flour
Eligibility
Inclusion Criteria:
Subject between 1 and 6 years of age
Diagnosed peanut allergy by RAST greater than or equal to 15 within past 6 months and have eaten peanut in diet resulting in a clinical reaction prior to diagnosis
Diagnosed peanut allergy by RAST greater than or equal to 7 within past 6 months and have had a clinical reaction to peanut ingestion within the past 6 months
Exclusion Criteria:
Subjects with a history of severe, anaphylaxis to peanut
Medical history that would prevent a DBPCFC/OFC to peanut
- Gender
Both
- Mininum Age
1 Year
- Maximum Age
7 Years
- Healthy Volunteers
No
Resources
Source: Duke University
Authority: United States: Food and Drug Administration
Locations
-
University of Arkansas Medical Center
Little Rock
Arkansas
72202
United States
Officials
Arvil W Burks, MD (Principal Investigator, Duke University)
Sponsors
Duke University (Lead Sponsor)
University of Arkansas (Collaborator)
References
None.
Links
None.
- Date Verified
- May 1st, 2011
- First Received
- May 5th, 2011
- Last Changed
- May 5th, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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